PerkinElmer 226 Sample Collection Device recallZ-2756-2017 · PerkinElmer Health Sciences, Inc. · initiated May 31, 2017
Class III Terminated All recalls posted in July 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PerkinElmer Health Sciences, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
FDA root cause category: Packaging
What the company is doing
PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.
Recall details
- Recall number
- Z-2756-2017
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- May 31, 2017
- Posted by the FDA
- Jul 24, 2017
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Quantity
- 99,968 units
- Product code
- PJC
- FDA submissions
- K121864
- Distribution
- US Distribution to the state of : AL
Product description
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
Code information (models, lots, serial numbers)
lot numbers 317113 and 317114
Other devices under the same FDA submission
1 device cleared under K121864 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Revvity 226 Newborn Screening CardRevvity, Inc. · Newborn Screening Specimen Collection Paper1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page